Identity
- Trade Name
- RigiSoft™ EUDAMED
- Device Name
- RigiSoft™ Malleable Penile Prosthesis EUDAMED
- Model / Reference
- Dia: 10 mm EUDAMEDRGS1010 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850033207682 EUDAMED
- Basic UDI-DI
- B-00850033207682 EUDAMED
- EMDN Code
- P080202 PENILE PROSTHESES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
RigiSoft™ by Rigicon, Inc. — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00850033207682 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Rigicon, Inc.
- EUDAMED SRN
- US-MF-000027758
- Authorised Representative
- Rigicon B.V. NL-AR-000013173
Sources (1)
- EUDAMED a274a058-d738-4dc8-b2f9-3b1aa7b60a40 61 fields · synced Jun 20, 2026